At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

The Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets, capsules, powders and liquids to over 60+ markets. The Mt Vernon site is the largest AZ production site in the US and is located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state of Indiana. The Mt. Vernon site is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives.

We are a team of results-oriented people, who want to go far, and we’re all here to achieve. It’s what drives us to be proactive and solutions-focused. At every stage of production, we step up and take accountability to deliver, each of us feeling responsible for the outcomes. What we do is important and valued – we make a real-life difference to patients. Here we have built an outstanding reputation in Quality, through our ‘Total Quality’ culture that takes us beyond pure compliance.

Why Join Quality?

Develop your expertise by being both challenged and supported to apply a ‘modern’ Quality mindset. It means taking accountability and making brave decisions. Whether that’s reimagining the best way to respond to procedures and regulations, or pushing back when there’s disagreement. We partner and problem-solve with product and process experts to ensure we perform with excellence across the Quality network.

What you’ll do:

Are you passionate about helping organizations transform effectively? Are you looking for an opportunity to help AstraZeneca in its digital transformation journey? We will rely on your ability to understand the effects of change in an organization and how to mitigate challenges effectively as we continue to deliver world class solutions. You will work in Business Systems helping to deliver our digital transformation portfolio.

The Compliance Specialist is responsible for providing both tactical and strategic support for Compliance and Quality activities within operations or sites.

• Support all Compliance programs and execute required Compliance activities to ensure the site meets current GMP requirements of all local/global regulations and internal AZ Quality and Compliance policies.
• Provide support to Quality Systems processes including but not limited to: Complaints, Quality Events/Deviations, CAPA, Change Control, Product Reviews, Supplier Quality, Internal Audit Program, and other Quality Systems as needed to support the site.
• Drive continuous improvements efforts through monitoring/evaluation of site systems & processes against current Compliance requirements and influencing key partners on recommended Compliance improvements.
• Support inspections of site by External Customers, internal assessors, and Regulatory authorities.
• Support in the preparation, planning & logistics, inspection management, and response/follow up for Customer and Regulatory Agency Inspections.
• Collaborate with/Influence key operations customers to drive the site Compliance Improvement Program.

Essential for the role:

• Bachelor’s degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering.
• 3 years’ experience in the pharmaceutical industry and/or FDA experience.
• Excellent oral and written communication skills and strong ability and motivation to learn.
• Ability to collaborate and participate in multi-disciplinary teams.
• Knowledge of cGMP requirements and industry best-practices.
• Familiarity with production operations.
• Strong technical writing.
• Strong interpersonal, communication, and influencing skills.

Desired for the role:

• Experience leading Quality Systems
• 2 years in Quality Assurance/Compliance

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be an excellent fit, please share this posting with them.

Find out more on Social Media:

LinkedIn https://www.linkedin.com/company/1603/

Facebook https://www.facebook.com/astrazenecacareers/

Instagram https://www.instagram.com/astrazeneca/?hl=en

About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.